Job summary
An exciting opportunity has become available at our Pharmaceutical Manufacturing Unit for Portsmouth Hospital University. If you have a passion for quality control and patient safety, delivered through the production of vital medication, this could be the role for you.
Main duties of the job
Our offsite facility supplies not only Portsmouth Hospitals NHS Trust, but number of other NHS Trusts across the country. This unit is going through some exciting changes in regard to future plans, you will play a key part in the development and implementation of these plans, ensuring the future success of the unit and the continued care for the patients within Portsmouth Hospitals NHS Trust. You will be supported by a diverse and energetic team of professional Pharmacist and Pharmacy Technicians.
About us
Here at Portsmouth Hospitals University NHS Trust, we are proud to provide expert, compassionate care for our local population. We are ranked as the third in the country for research, embedding education and training across the organisation. Our main hub is the Queen Alexandra Hospital, which is one of the largest hospitals on the south coast employing over 8,700 staff.
Our patients come from all walks of life and so do we. We hire great people from a wide variety of backgrounds because it makes our hospital stronger. If you share our values and our enthusiasm for getting it right for patients, colleagues, and our community, you will find a home at Portsmouth Hospitals University NHS Trust.
Job description
Job responsibilities
- To perform final product approval (releasing officer) for items produced under the MHRA Manufacturer's Specials Licence and, if appropriate, for items produced under Section 10 of the Medicines Act 1968 and Regulation 37 of The Medicines for Human Use (Clinical Trials) Regulations 2004.
- To ensure finished products are examined for their compliance with approved specifications and fitness for their intended purpose and to release or reject each batch as appropriate. This will require consideration of all factors relevant to the batch release including facility status, staff training status, production documentation review, and the final product.
- Apply specialist technical knowledge of good manufacturing practice and quality systems to ensure development and maintenance of quality control and assurance, including quality monitoring; preparation and review of work instructions; investigating quality deviations, non-conformances, and complaints and reporting to pharmacy management in accordance with procedures.
Job description
Job responsibilities
- To perform final product approval (releasing officer) for items produced under the MHRA Manufacturer's Specials Licence and, if appropriate, for items produced under Section 10 of the Medicines Act 1968 and Regulation 37 of The Medicines for Human Use (Clinical Trials) Regulations 2004.
- To ensure finished products are examined for their compliance with approved specifications and fitness for their intended purpose and to release or reject each batch as appropriate. This will require consideration of all factors relevant to the batch release including facility status, staff training status, production documentation review, and the final product.
- Apply specialist technical knowledge of good manufacturing practice and quality systems to ensure development and maintenance of quality control and assurance, including quality monitoring; preparation and review of work instructions; investigating quality deviations, non-conformances, and complaints and reporting to pharmacy management in accordance with procedures.
Person Specification
Qualifications
Essential
- Degree in Pharmacy
- Registered with the general pharmaceutical council
- OR
- Formal qualification in Chemistry or Biology
- Registered with the Royal society of Chemistry or Biology
Desirable
- Formal qualification as an accredited product approver
Experience
Essential
- Previous work experience within the NHS is desirable
- Thorough understanding of GMP and the requirements of the MHRA
- A good understanding of current microbiological or chemical methods and instruments used in QA/QC
- An excellent understanding of equipment and techniques used in aseptic manufacturing or compounding
- Working experience as a Releasing Officer
Person Specification
Qualifications
Essential
- Degree in Pharmacy
- Registered with the general pharmaceutical council
- OR
- Formal qualification in Chemistry or Biology
- Registered with the Royal society of Chemistry or Biology
Desirable
- Formal qualification as an accredited product approver
Experience
Essential
- Previous work experience within the NHS is desirable
- Thorough understanding of GMP and the requirements of the MHRA
- A good understanding of current microbiological or chemical methods and instruments used in QA/QC
- An excellent understanding of equipment and techniques used in aseptic manufacturing or compounding
- Working experience as a Releasing Officer
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
